We make your systems fit for new requirements

Process highly potent/highly effective active ingredients in a safe production environment

The development and use of highly active pharmaceutical ingredients, both biotechnical APIs and chemical APIs, is constantly increasing. This is associated with increased demands on containment when handling and processing the substances.

We support you in your responsibility for people, products and the environment and work with you to find the suitable combination of the right level of containment and efficient production. Containment considerations and an appropriate containment strategy already play a central role in the early project phases.

Processing YOUR highly active pharmaceutical ingredients in a safe production environment

Ensuring product quality, such as avoiding cross-contamination, and guaranteeing occupational safety and environmental protection are in the focus of our considerations. Thereby, the required safety measures for production are based on a risk assessment developed by the customer. Right from the beginning we take the approach of developing and evaluating concepts together with you, the customer, and working out the most suitable concept for your specific project.

Maximum product safety and occupational safety by tailored risk-based approach

The exposure level of the substances (Occupational Exposure Limit) and the procedural and process-related risks determine the necessary containment measures. Our specialists will support you by analyzing the risks in your process environment and determining the hazard potential within your risk assessment.

Factors such as substance quantity, duration and frequency of exposure play a key role in deriving the necessary containment measures.

S)TOP method, we first concentrate on developing a suitable primary containment solution. Of course, we also have the expertise to support your needs for secondary containment, such as suitable room and airlock concepts or pressurized zone and HVAC concepts.

Containment Facts for the decision-makers

• For pharmaceutical production, the trend towards increasingly potent active ingredients results in mounting personal protection requirements for operating personnel.
• Aside from the toxicological data for the active ingredient, operator exposure as well as frequency of production cycles also play an important role.
• Efficiency and cost-effectiveness criteria must always be examined to determine whether investment in system technology is worthwhile or whether procuring personal protective equipment for the operator makes more sense.